Atossa Therapeutics, Inc. and Quantum Leap Healthcare Collaborative have provided an enrollment update for the (Z)-Endoxifen arm of the ongoing I-SPY 2 clinical trial. Six patients have been dosed with Atossa's proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, which is being evaluated as a neoadjuvant treatment for patients with newly diagnosed estrogen receptor-positive invasive breast cancer.
The I-SPY 2 trial is a collaborative effort among academic investigators, Quantum Leap Healthcare Collaborative, the FDA, and the Foundation for the National Institutes of Health. The (Z)-endoxifen treatment arm is part of the I-SPY 2 Endocrine Optimization Pilot Protocol and is expected to enroll approximately 20 patients who will receive daily doses of (Z)-endoxifen prior to surgery.
Dr. Steven Quay, Atossa's President and CEO, stated that reaching 30% enrollment in the study is an important milestone in their development program for (Z)-endoxifen. He emphasized the need for novel treatments options that are